FDA.reportPublic FDA data

Koya Medical

Primary DI
00850012532019
Brand
Koya Medical
Company
Koya Medical, Inc.
Model
F-0010-02
Catalog number
F-0010-02
Device description
Arm Garmet, Dayspring, Medium
Published
2020-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSLEEVE, LIMB, COMPRESSIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193288000Koya RippleKoya, Inc.2020-06-16JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012532019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012532019008500125320198500125320190850012532019

GMDN Terms#

Term, Definition table
TermDefinition
Wearable sequential venous compression systemA noninvasive, electrically-powered, entirely patient-worn device assembly intended to improve venous and lymphatic return from the leg to help treat/prevent venous disorders/sequelae (e.g., swelling, pain, thrombosis). It consists of an electronic processor with a compressing mechanism (e.g., pump, contracting straps) intended to be strapped to the calf, which provides a continuous peristaltic wave motion, and used for prescribed periods of treatment. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for hospitalized/institutionalized patients.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(833)999-5692tori@koyamedical.com

Regulatory Flags#

DUNS number
100673310
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012532705DAYSPRINGF-0010-072025-01-31
00850012532712DAYSPRINGF-0010-082025-01-31
00850012532729DAYSPRINGF-0010-092025-01-31
00850012532736DAYSPRINGF-0050-022025-01-31
00850012532743DAYSPRINGF-0040-032025-01-31
00850012532750DAYSPRINGF-0040-042025-01-31
00850012532767DAYSPRINGF-0040-052025-01-31
00850012532774DAYSPRINGF-0040-062025-01-31
00850012532781DAYSPRINGF-0040-072025-01-31
00850012532798DAYSPRINGF-0040-082025-01-31
00850012532675DAYSPRING ARM GARMENTF-0010-042023-09-20
00850012532682DAYSPRING ARM GARMENTF-0010-052023-09-20
00850012532699DAYSPRING ARM GARMENTF-0010-062023-09-20
00850012532620DAYSPRINGF-0040-01F-0040-012022-05-16
00850012532637DAYSPRINGF-0040-02F-0040-022022-05-16
00850012532644DAYSPRINGF-0050-01F-0050-012022-05-16
00850012532002Koya MedicalF-0010-01F-0010-012020-12-15
00850012532026Koya MedicalF-0010-03F-0010-032020-12-15
00850012532101Koya MedicalF-0002-01F-0002-012020-12-15
00850012532057Koya MedicalF-0020-02F-0020-022020-12-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00636257221785MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00636257221792MEDIMEDI MANUFACTURING, INC.JOW2026-10-27
00850078826213BioTAB LLCBiotab LLCJOW2026-10-26
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00850078826282BioTAB LLCBiotab LLCJOW2026-10-26
00850078826299BioTAB LLCBiotab LLCJOW2026-10-26
00850078826305BioTAB LLCBiotab LLCJOW2026-10-26
00850078826312BioTAB LLCBiotab LLCJOW2026-10-26
00850078826329BioTAB LLCBiotab LLCJOW2026-10-26
00850031012769AIROSAIROS MEDICAL INCJOW2026-10-09
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00812311022486Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00190446979128AIRCASTDJO, LLCJOW2026-08-03
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50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31